This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2 genital herpes. Part A will focus on the safety evaluations, and in addition, vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Part B of the trial will expand the safety characterization for two dose levels of BNT163 selected based on Part A data and will also enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and immune responses to BNT163. Part C will evaluate safety and immunogenicity of BNT163 compared to a placebo in a three-dose regimen in participants with a history of HSV-2 recurrent genital herpes.
In Part A, participants will be randomized 5:1 to BNT163:placebo. In Part B, participants will be randomized 1:1 to either of the two selected dose levels based on data from Part A. In Part C, participants will be randomized 1:1 to BNT163:placebo. In Part A \& B, participants will receive three intramuscular doses of a fixed dose level of the BNT163 vaccine (Part A and B) or placebo (Part A only). In Part C, participants will receive three intramuscular doses of one fixed dose level of the BNT163 vaccine or placebo. In this part, continuous suppressive antiviral therapy is given over the entire vaccine dosing period (during and between vaccine doses) to prevent administration of the vaccine concomitantly to viral replication and active genital herpes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
318
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States
Great Lakes Clinical Trials - Flourish Research
Chicago, Illinois, United States
Accellacare Raleigh Medical Group
Raleigh, North Carolina, United States
Accellacare PMG Research Wilmington LLC
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
For each dose level (DL) per BNT163 dosing schedule and for the combined placebo group.
Time frame: Up to 7 days after each dose
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose
For each DL per BNT163 dosing schedule and for the combined placebo group.
Time frame: Up to 7 days after each dose
Percentage of participants with at least one unsolicited adverse event (AE) occurring up to 28 days after each dose
For each DL per BNT163 dosing schedule and for the combined placebo group.
Time frame: From Day 1 up to Day 197
Percentage of participants in each cohort with at least one serious AE, or AE of special interest, or medically attended AE occurring up to 24 weeks post-Dose 3 (Parts A & B) or post-Dose 2 (Part C)
For each DL per BNT163 dosing schedule and for the combined placebo group.
Time frame: From Day 1 up to Day 337
Number of unsolicited AEs occurring up to 28 days after each dose
For each DL per BNT163 dosing schedule and for the combined placebo group.
Time frame: From Day 1 up to Day 197
Percentage of unsolicited AEs occurring up to 28 days after each dose
For each DL per BNT163 dosing schedule and for the combined placebo group.
Time frame: From Day 1 up to Day 197
Geometric mean titer (GMT) at each time point
HSV-2 glycoproteins (g)C2, gD2, and gE2 binding antibody titers enzyme-linked immunosorbent assay (ELISA). HSV-2 neutralizing antibody titers. For each DL per BNT163 dosing schedule at baseline, 7 days (Parts A \& B only) and 28 days after each dose and at 24 weeks post-Dose 3 (all parts) and for the combined placebo group.
Time frame: From Day 1 up to Day 337
Geometric mean fold (GMF) change from baseline of neutralizing and binding antibody titers to each time point after vaccination
HSV-2 gC2, gD2, and gE2 binding antibody titers ELISA. HSV-2 neutralizing antibody titers. For each DL per BNT163 dosing schedule at baseline, 7 days (Parts A \& B only) and 28 days after each dose and at 24 weeks post-Dose 3 (all parts) and for the combined placebo group.
Time frame: From Day 1 up to Day 337
Part A and B only - Percentage of participants with seroconversion defined as a minimum of 4-fold increase from baseline of neutralizing and binding antibody titers to each subsequent time point after vaccination
For each DL per BNT163 dosing schedule at baseline, 7 days (Parts A \& B only) and 28 days after each dose and at 24 weeks post-Dose 3 (all parts) and for the combined placebo group.
Time frame: From Day 1 up to Day 337
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.